Antares Pharma Announces Submission of New Drug Application for OTREXUP™

Antares Pharma, Inc. (NASDAQ: ATRS) today announced the submission of a
New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for OTREXUP™, a combination product for the delivery of
methotrexate (MTX) using Medi-Jet™ technology. OTREXUP was developed for
easy subcutaneous administration of MTX to enhance the treatment of
rheumatoid arthritis (RA), poly-articular-course juvenile RA and
moderate to severe psoriasis.

“The NDA submission of OTREXUP represents yet another significant
accomplishment in the Company’s history,” said Paul K. Wotton Ph.D.,
President and Chief Executive Officer. “It is the first product designed
for convenient subcutaneous delivery of methotrexate in patients with
rheumatoid arthritis or psoriasis. We believe OTREXUP will benefit most
patients that have not reached a satisfactory response to oral
methotrexate alone or in combination with a biologic or another
disease-modifying anti-rheumatic drug.”

OTREXUP was developed to optimize the clinical benefit of MTX, leading
to cost effective treatment outcomes. Historically, parenteral MTX use
has been limited in clinical practice for several reasons including the
inconvenience of weekly intramuscular injections by a healthcare
professional, and/or the challenges associated with teaching patients
with impaired hand function, safe and sterile self-injection techniques.
Studies conducted to date indicate OTREXUP is safe, easy and comfortable
for RA patients to self-administer precise subcutaneous doses of MTX
with improved systemic availability compared to oral doses.

The NDA submission, subject to acceptance and approval by the FDA, was
supported by data generated from a clinical development program
completed in accordance with the FDA’s guidance and recommendations.
Antares executed and completed all of the clinical studies agreed with
the agency and described in the clinical development program.

“The dedicated efforts of the entire Antares team have allowed us to
submit a New Drug Application to the FDA ahead of schedule,” said
Kaushik J. Dave R.Ph., Ph.D., Executive Vice President Product
Development. “The results from the clinical development program have
shown that OTREXUP can provide greater systemic exposure to methotrexate
compared to oral doses. We believe OTREXUP is easy to use and
comfortable for RA patients with moderate to severe hand function
impairment thereby enhancing self-administration and patient compliance.”

About Medi-Jet and Methotrexate

Medi-Jet is a proprietary parenteral drug delivery system protected by
several issued and pending patents. Medi-Jet is designed to enable
patients to quickly and easily self-administer a drug subcutaneously or
intramuscularly, reliably and comfortably while also enhancing safety
with an integrated, shielded needle that protects against accidental
needle stick and drug exposure. Medi-Jet is a trademark of Antares
Pharma.

Methotrexate is a commonly prescribed disease-modifying anti-rheumatic
drug (DMARD), used in an estimated 70% of rheumatoid arthritis patients
either on its own or in combination with biological therapies.
Methotrexate is started at a low dose, generally 7.5mg given orally,
once-a-week, and titrated up for greater therapeutic effect, or until
the patient incurs side effects. The maximum oral dose given is
generally 20mg to 25mg per week. Published studies have reported that
30% to 60% of patients experience gastrointestinal side effects with
oral methotrexate, preventing further dose escalation or requiring
discontinuation in some patients. Oral absorption of methotrexate varies
considerably between patients and between doses in the same patient and
has been shown to decline with increasing doses, which may also
contribute to insufficient therapeutic response even after dose
escalation. Switching patients from oral to parenteral methotrexate
improves absorption and has been associated with improved therapeutic
response. Additionally, some studies have shown a lower incidence of
gastrointestinal side effects in patients that were switched from oral
to parenteral methotrexate.

About Rheumatoid Arthritis

Rheumatoid Arthritis is a form of inflammatory arthritis and an
autoimmune disease. In rheumatoid arthritis, the immune system – which
is designed to protect our health by attacking foreign cells such as
viruses and bacteria – instead attacks the body’s own tissues,
specifically the synovium, a thin membrane that lines the joints. As a
result of the attack, fluid builds up in the joints, causing pain
in the joints and inflammation
that’s systemic – meaning it can occur throughout the body. Rheumatoid
arthritis is a chronic, incurable disease. Most people with RA
experience intermittent bouts of intense disease activity, called flares.
In some people the disease is continuously active and gets worse over
time. Evidence shows that early diagnosis and treatment to put the
disease into remission is the best means of avoiding joint destruction,
organ damage and disability.

About Psoriasis

Psoriasis is a chronic, autoimmune disease that appears on the skin. It
occurs when the immune system sends out faulty signals that speed up the
growth cycle of skin cells. Psoriasis is not contagious. There are five
types of psoriasis. The most common form, plaque psoriasis, appears as
raised, red patches covered with a silvery white build-up of dead skin
cells. Psoriasis can occur on any part of the body and is associated
with other serious health conditions, such as diabetes, heart disease
and depression. Psoriasis is the most common autoimmune disease in the
U.S. According to the National Psoriasis Foundation, as many as 7.5
million Americans have psoriasis.

About Antares Pharma

Antares Pharma focuses on self-administered parenteral pharmaceutical
products and topical gel-based medicines. The Company's technology
platforms include VIBEX™ disposable Medi-Jet, disposable multi-use pen
injectors and Vision™ reusable needle-free injectors marketed as Tjet®
and Zomajet® by Teva Pharmaceutical Industries, Ltd (Teva)
and Ferring Pharmaceuticals (Ferring), respectively. Antares Pharma has
a multi-product deal with Teva that includes Tev-Tropin®
human growth hormone (hGH), VIBEX epinephrine and several other
products. Antares Pharma’s partnership with Ferring includes Zomacton®
hGH. In the U.S. Antares has received FDA approval for Gelnique 3%™, a
treatment for overactive bladder that is marketed by Watson
Pharmaceuticals, Inc. Elestrin® (estradiol gel) is FDA
approved for the treatment of moderate-to-severe vasomotor symptoms
associated with menopause, and is marketed in the U.S. by Meda Pharma.
Antares Pharma has two facilities in the U.S. The Parenteral Products
Group located in Minneapolis, Minnesota directs the manufacturing and
marketing of the Company’s reusable needle-free injection devices and
related disposables, and develops its disposable pressure-assisted
Medi-Jet and pen injector systems. The Company’s corporate office and
Product Development Group are located in Ewing, New Jersey.

Forward-Looking Statement

This press release contains forward-looking statements within the
meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These statements are indicated by the
words “may,” “will,” “plans,” “intends,” “believes,” “expects,”
“anticipates,” “potential,” “could,” “would,” “should,” and similar
expressions. Such forward-looking statements are not guarantees of
future performance and are subject to risks and uncertainties that may
cause actual results to differ materially from those anticipated by the
forward-looking statements. These risks and uncertainties include, among
others, changes in revenue growth and difficulties or delays in the
initiation, progress, or completion of product development. Additional
information concerning these and other factors that may cause actual
results to differ materially from those anticipated in the
forward-looking statements is contained in the "Risk Factors" section of
the Company's Annual Report on Form 10-K for the year ended December 31,
2011, and in the Company's other periodic reports and filings with the
Securities and Exchange Commission. The Company cautions investors not
to place undue reliance on the forward-looking statements contained in
this press release. All forward-looking statements are based on
information currently available to the Company on the date hereof, and
the Company undertakes no obligation to revise or update these
forward-looking statements to reflect events or circumstances after the
date of this press release, except as required by law.